FDA Label for Benz O Sthetic
View Indications, Usage & Precautions
Benz O Sthetic Product Label
The following document was submitted to the FDA by the labeler of this product Geritrex Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drugs Facts
Active Ingredients Purpose
Benzocaine 20%........................Oral Anesthetic
Uses
Topical anesthetic for the temporary relief of occasional minor irritation and pain, associated with:
canker sores
- sore mouth and throat
- minor dental procedures
- minor irritation of the mouth and gums caused by dentures or orthodontic appliances
- minor injury of the mouth and gums
Directions
May be used with extension tube for finer direct application. For adults and children 2 years and older anesthetic use in mouth or throat:
Pump spray 2-3 times up to 4 times. Repeat if needed for larger areas. Anesthetic effect is reached in 15-30 seconds. Children under 12 years of age should be supervised and use as directed by dentist/doctor.
Warnings
Do not use this product if patient has a history of allergy to local anesthetics
such as procaine, butacaine, benzocaine, or other “caine” anesthetics. Do not
spray into or near eyes. Do not inhale.
Patient: When using extension tube, do not spray in the back of the throat
unless your dentist or doctor directed you to do so.
When using this product:
- Avoid use near eyes
- Do not use more than recommended dosage
- Do not go beyond 7 days usage, unless directed by your doctor/dentist
Patient: Discontinue use and consult a physician if: sore mouth symptoms do
not improve in 5 days; irritation, pain, or redness persists or worsens;
swelling, rash, or fever develops.
Other Ingredients
Alcohol, benzyl alcohol, flavor, peppermint oil, polyethylene glycol, sodium saccharin
Other Information:
store at controlled room temperature 20-25°C (68-77°F)
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Warnings And Precautions
Caution: If accidental or excessive ingestion occurs (exceeds recommended dosage) contact a physician for immediate advice or call a Poison Control Center.
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